P
US9877933B2ActiveUtilityPatentIndex 91

Method of administering amantadine prior to a sleep period

Assignee: ADAMAS PHARMA LLCPriority: Dec 2, 2009Filed: Feb 9, 2017Granted: Jan 30, 2018
Est. expiryDec 2, 2029(~3.4 yrs left)· nominal 20-yr term from priority
Inventors:WENT GREGORY TSATHYAN GAYATRIVERMANI KAVITAGANAPATI GANGADHARACOFFEE MICHAELSHEK EFRAIMKATDARE ASHOK
A61P 25/28A61P 25/16A61P 25/14A61P 25/20A61P 25/00A61K 9/0004A61K 9/0002A61K 31/13A61K 9/5078A61K 9/48A61K 9/5047A61K 9/0053A61K 9/14A61K 9/5026A61K 9/4808A61K 9/50A61K 31/198A61K 9/5015A61K 9/4891
91
PatentIndex Score
15
Cited by
623
References
31
Claims

Abstract

Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A method of treating a patient with Parkinson's disease, comprising administering once daily, 0 to 4 hours before bedtime, to said patient with Parkinson's disease, a pharmaceutical composition comprising: (i) 220 mg to 455 mg of a drug selected from the group consisting of amantadine and a pharmaceutically acceptable salt thereof; and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form,
 wherein ON time without troublesome dyskinesia is increased in said patient with Parkinson's disease, and 
 wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Tmax for the drug is 8 to 20 hours. 
 
     
     
       2. The method of  claim 1 , wherein said increased ON time without troublesome dyskinesia is determined from a Parkinson's disease home diary. 
     
     
       3. The method of  claim 1 , wherein said Tmax is 9 to 18 hours. 
     
     
       4. The method of  claim 1 , wherein said Tmax is 11 to 18 hours. 
     
     
       5. The method of  claim 1 , wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the AUC 0-inf  for the drug is 40 to 75 ng*hr/ml per mg of the drug. 
     
     
       6. The method of  claim 1 , wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC 0-24  for the drug is 44 to 83 ng*hr/ml per mg of the drug. 
     
     
       7. The method of  claim 1 , wherein said pharmaceutical composition is administered to said patient once daily, 0 to 3 hours before bedtime. 
     
     
       8. The method of  claim 1 , wherein said pharmaceutical composition comprises 1 or 2 unit dosage forms. 
     
     
       9. The method of  claim 1 , wherein said pharmaceutical composition comprises one, two, or three capsules. 
     
     
       10. A method of treating a patient with Parkinson's disease, comprising administering once daily, 0 to 4 hours before bedtime, to said patient with Parkinson's disease, a pharmaceutical composition comprising: (i) 220 mg to 445 mg of a drug selected from the group consisting of amantadine and a pharmaceutically acceptable salt thereof; and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form,
 wherein ON time without troublesome dyskinesia is increased in said patient with Parkinson's disease, and 
 wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Cmax for the drug is 1.0 to 2.8 ng/ml per mg of the drug and the AUC 0-inf  for the drug is 40 to 75 ng*h/ml per mg of the drug. 
 
     
     
       11. The method of  claim 10 , wherein said increased ON time without troublesome dyskinesia is determined from a Parkinson's disease home diary. 
     
     
       12. The method of  claim 10 , wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Tmax for the drug is 8 to 18 hours. 
     
     
       13. The method of  claim 10 , wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Tmax for the drug is 9 to 18 hours. 
     
     
       14. The method of  claim 10 , wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Tmax for the drug is 11 to 18 hours. 
     
     
       15. The method of  claim 10 , wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC 0-24  for the drug is 44 to 83 ng*hr/ml per mg of the drug. 
     
     
       16. The method of  claim 10 , wherein said pharmaceutical composition is administered to said patient once daily, 0 to 3 hours before bedtime. 
     
     
       17. The method of  claim 10 , wherein said pharmaceutical composition comprises 1 or 2 unit dosage forms. 
     
     
       18. The method of  claim 10 , wherein said pharmaceutical composition comprises one, two, or three capsules. 
     
     
       19. The method of  claim 10 , wherein said drug is a pharmaceutically acceptable salt of amantadine. 
     
     
       20. The method of  claim 10 , wherein said drug is amantadine hydrochloride. 
     
     
       21. The method of  claim 10 , wherein said pharmaceutical composition is selected from the group consisting of one unit dosage form comprising 340 mg of said drug and two unit dosage forms each comprising 170 mg of said drug. 
     
     
       22. The method of  claim 21 , wherein said drug is a pharmaceutically acceptable salt of amantadine. 
     
     
       23. The method of  claim 21 , wherein said drug is amantadine hydrochloride. 
     
     
       24. The method of  claim 1 , wherein said drug is a pharmaceutically acceptable salt of amantadine. 
     
     
       25. The method of  claim 1 , wherein said drug is amantadine hydrochloride. 
     
     
       26. The method of  claim 1 , wherein said pharmaceutical composition is selected from the group consisting of one unit dosage form comprising 340 mg of said drug and two unit dosage forms each comprising 170 mg of said drug. 
     
     
       27. The method of  claim 26 , wherein said drug is a pharmaceutically acceptable salt of amantadine. 
     
     
       28. The method of  claim 26 , wherein said drug is amantadine hydrochloride. 
     
     
       29. The method of  claim 1 , wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Cmax for the drug is 1.0 to 2.8 ng/ml per mg of the drug. 
     
     
       30. The method of  claim 29 , wherein the Cmax for the drug is 1.0 to 2.4 ng/ml per mg of the drug. 
     
     
       31. The method of  claim 10 , wherein the Cmax for the drug is 1.0 to 2.4 ng/ml per mg of the drug.

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